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The purpose of this study is to assess the safety and efficacy of a subcutaneous injection of nL-SAA1-01in a patient with AA Amyloidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nL-SAA1-01 | Experimental | Subject will receive subcutaneous injection of nL-SAA1-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nL-SAA1-01 | Drug | Personalized antisense oligonucleotide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and/or serious adverse events | Number of adverse events and/or serious adverse events experienced | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in kidney function | The change in kidney function is measured by the glomerular filtration rate (GFR) | Baseline, 1 year |
| Change in quality of life - physical well-being | Physical well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Leung, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C000718787 | AA amyloidosis |
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| Baseline, 1 year |
| Change in quality of life - emotional well-being | Emotional well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life. | Baseline, 1 year |
| Change in quality of life - spiritual well-being | Spiritual well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life. | Baseline, 1 year |
| Change in quality of life - intellectual well-being | Intellectual well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life. | Baseline, 1 year |
| Change in quality of life - overall well-being | Overall well-being will be measured using a Linear Analog Scale Assessment (LASA) The Likert scale runs from 0 (as bad as possible) to 10 (as good as possible) where a higher rating suggest a higher quality of life. | Baseline, 1 year |
| Initiation of dialysis | The amount of time between the first dose of the investigational product and the need for dialysis | 1 year |
| Initiation of kidney transplantation | The amount of time between the first dose of the investigational product and the need for a kidney transplantation. | 1 year |